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Novel Post-surgical Incision Management Device to Prevent Ostomy Complications

预防造口并发症的新型术后切口管理装置

基本信息

批准号：
10590062
负责人：
Andrew T Obst
金额：
$ 77.31万
依托单位：
FISTULA SOLUTION CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-03-01 至 2026-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10590062
关键词：
Abdomen Accidents Adhesives Age Agreement Blood flow Body mass index Clinical Clinical Trials Colon Carcinoma Colorectal Cancer Crohn&apos s disease Data Device Designs Device Safety Devices Diverticulitis Edema Ensure Feces Fistula Goals Hand Health Health Benefit Health Care Costs Healthcare Systems Home Hospitals Human Inflammatory Bowel Diseases Injury International Intestinal Diseases Intestinal Obstruction Intestines Leaky Gut Length of Stay Life Liquid substance Manuals Medical Minnesota Operative Surgical Procedures Ostomy Outcome Patient Discharge Patient-Focused Outcomes Patients Pelvis Performance Phase Population Procedures Process Production Prosthesis Randomized, Controlled Trials Rectal Cancer Reporting Research Risk Safety Secure Skin Small Business Innovation Research Grant Standardization Sterility Stomas Surgical incisions Surgical sutures Swelling Technology Testing Therapeutic Tissues Traction Trauma Ulcerative Colitis United States United States Centers for Medicare and Medicaid Services Vacuum Work abdominal wall biomaterial compatibility clinically significant commercialization cost design design verification efficacy testing experience healing high body mass index hospital readmission improved innovation intestinal injury manufacturability manufacture manufacturing capabilities manufacturing process manufacturing test military service novel patient safety pressure prevent repaired seal skin damage standard of care tissue oxygenation trial comparing wasting wound care

项目摘要

Project Summary/Abstract Over 100,000 patients of all ages undergo ostomy surgery in the United States (US) annually due to a variety of pathophysiologic conditions including colorectal cancer, inflammatory bowel disease (Crohn’s disease and ulcerative colitis), bowel obstruction, diverticulitis, and many other medical conditions. Ostomy surgery may also be necessary in cases of severe abdominal or pelvic trauma resulting from accidents or from injuries sustained during military service. A life-saving procedure, ostomy surgery allows bodily waste to pass through a surgically created opening called a stoma on the abdomen into a prosthetic known as a ‘pouch’ or ‘ostomy bag’ on the outside of the body. Patients are discharged from the hospital within days of ostomy creation and expected to heal at home using disposable ostomy pouches attached to the skin around their stoma. Unfortunately, current pouch designs offer little therapeutic benefit for post-surgery edema (swelling) and may not maintain a tight seal, allowing leakage of intestinal fluid and waste. Resulting stoma complications include mucocutaneous (skin/stoma) separation, stoma retraction, and moisture-associated skin damage. Up to 70% of ostomy patients endure these complications, with 29% of these patients requiring hospital readmissions at an additional cost of $78,000 per patient. Furthermore, risks for complications are higher for high body mass index (BMI) patients. Given the rise in clinical conditions requiring ostomy surgery, the increased BMI of the US population, and the current reimbursement landscape that penalizes the healthcare system for readmissions, an improved post- surgical incision management device to prevent ostomy complications is urgently needed. In this SBIR Direct Phase II, Fistula Solution will develop a novel post-surgical ostomy incision management device designed to prevent complications, form a tight seal, and protect the new stoma. This device stabilizes the tissue around the stoma to reduce edema and tension on sutures, along with holding the skin/stoma junction together to facilitate healing. In addition, the device creates a secure seal to stop stool leaks and prevent MASD. Our specific aims are to 1) optimize product design for manufacturability and clinical benefits; 2) verify product design and biocompatibility; and 3) conduct a clinical trial comparing the device to conventional adhesive ostomy pouches with HealthPartners Institute and Regions Hospital in St. Paul, Minnesota. The successful execution of our specific aims will establish device safety and efficacy and ensure the device is designed for manufacturability and biocompatibility. The human health benefit is a new standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions to hospital, and mitigate a major financial exposure for hospitals.

项目总结/文摘